he Central Drugs Standard Control Organization (CDSCO) has issued a new public notice dated 4 May 2026 regarding the disposal and rejection of long-pending applications on the SUGAM portal due to non-submission of query responses by applicants.
This initiative has been introduced to reduce the backlog of applications pending across various CDSCO divisions, including GCT, BABE, Ethics Committee, and Veterinary divisions. Applications pending since 2016 are also being reviewed under this process.
Why CDSCO Issued This Notice
CDSCO observed that a large number of applications remain pending because applicants failed to respond to queries raised during the evaluation process. To streamline regulatory operations and improve application processing timelines, CDSCO has implemented a structured reminder mechanism through the SUGAM portal and email communication.
Under this mechanism, applicants receive multiple reminders to submit their pending responses within prescribed timelines.
CDSCO Reminder & Rejection Process
As per the notice, CDSCO follows a four-step communication process:
Reminder Timeline Structure
- 1st Reminder – Issued for old pending files
- 2nd Reminder – Sent after 30 days from the 1st reminder
- 3rd Reminder – Sent after 30 days from the 2nd reminder
- 4th Disposal/Rejection Notice – Issued after 30 days from the 3rd reminder
If applicants fail to respond even after the three reminders, CDSCO issues a final communication stating that:
- The application stands rejected
- The application fee is forfeited
- No further processing will be carried out
Important Update for Stakeholders
CDSCO has specifically informed stakeholders that applications pending with applicants for more than two years, and already covered under the three-reminder process, will now be rejected after 30 days from the date of the public notice.
Applicants are strongly advised to:
- Regularly monitor the SUGAM portal
- Check registered email communications from CDSCO
- Submit query responses within stipulated timelines
- Avoid unnecessary delays that may lead to rejection and fee forfeiture
Impact on Pharma & Medical Device Companies
This notice is highly important for:
- Pharmaceutical manufacturers
- Medical device companies
- Clinical trial applicants
- Ethics committees
- Veterinary product manufacturers
- Regulatory affairs professionals
Failure to respond to CDSCO queries on time can result in loss of application fees, regulatory delays, and the need to refile applications from the beginning.
Conclusion
The latest CDSCO public notice highlights the importance of timely regulatory compliance and proactive communication through the SUGAM portal. Stakeholders must ensure that all pending queries are addressed promptly to avoid rejection of applications and forfeiture of fees.
Companies handling regulatory submissions should establish strong tracking mechanisms for CDSCO communications to maintain smooth approval processes and regulatory compliance.